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Bioterrorism Preparedness Act of 2002

Public Health Security and Bioterrorism Preparedness Act of 2002
Public Law 107-877

***THIS NEW REGULATION COULD AFFECT YOUR RESEARCH***

July 12, 2002

If you conduct biomedical research, you need to know about this new regulation that addresses security of select infectious agents, toxins, and genetic elements (refer to attached list). The new law focuses on possession of materials that are not uncommon in biomedical research labs, and calls for DHHS to be more aggressive in tracking individuals who have them. This new law takes the Patriot Act to the next level.

The intensified concern over bioterrorism in the aftermath of September 11 and the subsequent anthrax incidents have caused Congress to increase its scrutiny of potential sources of biological agents that could pose a risk to the public’s health and safety, including the nation’s university laboratories. On May 22, the US House and Senate approved House Rule 3448 and President Bush signed it into law on June 12, 2002 (Public Law 107-188).

ACTION ITEM – Oversight of the Select Agents Program at the University of Michigan is accomplished through the Department of Occupational Safety and Environmental Health (OSEH). The contact is Michael Hanna at 7-2318. Please scour your memories, inventories, and Ultralow’s to determine if you are in possession of any of these regulated materials. Internal DEADLINE is August 30. If you suspect you’ve located a Select Agent, call OSEH and we’ll assist you in working through the required registration.

BACKGROUND – Since 1996 when Select Agents were first listed as more heavily regulated research materials by the CDC, OSEH has assisted the research community in dealing with these new regulations. In conjunction with the Office of the Vice President for Research (OVPR), the effort has been to alert and brief researchers on shipping restrictions for Select Agents. However, the new law dictates that you must register with the CDC if you merely possess these infectious agents, toxins, and genetic elements.

In the July 2^nd Federal Register (FR), the CDC published a proposed data collection system for notification of Select Agents possession. Section 202(a) of the Act requires that all persons in possession of a Select Agent notify the Secretary of Health and Human Services by September 10, 2002.

Excerpt from the FR notice "In order to complete the application, the RFO will need to inventory its facility and consult with others (e.g., principal investigators) as necessary to obtain the information required for this application. The Responsible Facility Official (RFO) must review and sign the application and will be the point of contact if CDC has questions concerning the application or other matters related to the Public Law."

Appendix A
Select Agents List as of January 1, 2002
[42CFR 72, Appendix A – October 24, 1996]

Viruses

1. Crimean-Congo haemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Equine Morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan Equine Encephalitis virus
12. Viruses causing hantavirus pulmonary syndrome
13. Yellow fever virus

Exemptions: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.

Bacteria

1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
6. Francisella tularensis
7. Yersinia pestis

Exemptions: vaccine strains as described in Title 9 CFR, 78.1 are exempt.

Rickettsiae

1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii

Fungi

1. Coccidioides immitis

Toxins

1. Abrin
2. Aflatoxins
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
5. Conotoxins
6. Diacetoxyscirpenol
7. Ricin
8. Saxitoxin
9. Shigatoxin
10. Staphylococcal enterotoxins
11. Tetrodotoxin
12. T-2 toxin

FROM FEDERAL REGISTER - JULY 12, 2002
"Preliminary Guidance for Notification of Possession of Select Agents"

INSTRUCTION FROM UM-OSEH TO RESEARCHERS - CDC AND USDA HAVE ADDED NEW AGENTS TO THE LIST. IF YOU HAVE ALREADY DONE A REVIEW OF YOUR COLLECTION FOR SELECT AGENT POSSESSION, REVIEW THE FINAL BLOCK AND RE-CHECK YOUR COLLECTION. IF ANY ARE IDENTIFIED, CONTACT OSEH AT 7-2318.

HHS Select Agents

1. Crimean-Congo Haemorrhagic Fever Virus
2. Ebola Viruses
3. Lassa Fever Virus
4. Marburg Virus
5. Richettsia prowazeki
6. Rickettsia rickettsii
7. South American Haemorrhagic Fever Viruses
8. Tick-Borne Enciphalitis Complex Viruses
9. Variola Major Viruses (Smallpox Virus)
10. Viruses Causing Hantavirus Pulmonary Syndrome
11. Yellow Fever Virus
12. Yersinia pestis
13. Abrin
14. Conotixins
15. Diacetoxyscirpenol
16. Ricin
17. Saxitoxin
18. Tetrodotoxin

USDA-HHS Overlap Agents

1. Bacillus anthracis
2. Brucella abortus
3. Brucella melitensis
4. Brucella suis
5. Burkholderia (Pseudomonas) mallei
6. Burkholderia (Pseudomonas) pseudomallei
7. Clostridium botulinum
8. Coccidioides immitis
9. Coxiella burnettii
10. Eastern Equine Encephalitis Virus
11. Equine Morbillivirus (Hendra Virus)/Nipah Virus
12. Francisella tularensis
13. Rift Valley Fever Virus
14. Venezuelan Equine Encephalitis Virus
15. Aflatoxins
16. Botulinum Toxins
17. Clostridium perfringens epsilon Toxin
18. Shigatoxin
19. Staphlococcal enterotoxin
20. T-2 Toxin

USDA High Consequence of Livestock Pathogens and Toxins

1. African Horse Sickness Virus
2. African Swine Fever
3. Akabane Virus
4. Avian Influenza Virus (Highly Pathogenic)
5. Blue Tongue Virus (Exotic)
6. Bovine Spongiform Encepalopathy Agent
7. Camel Pox Virus
8. Classical Swine Fever
9. Cowdria ruminantium (Heartwater)
10. Foot and Mouth Disease Virus
11. Goat Pox Virus
12. Japanese Encephalitis Virus
13. Lumpy Skin Disease Virus
14. Malignant Catarrhal Fever
15. Menangle Virus
16. Mycoplasma capricolum/M.F 38/M. mycoides capri (Contagious Caprine Pleuropneumonia Agent)
17. Mycoplasma mycoides mycoides (Contagious Bovine Pleuropneumonia Agent)
18. Newcastle Disease Virus (Exotic)
19. Peste Des Petits Ruminants
20. Rinderpest Virus
21. Sheep Pox
22. Swine Vesicular Disease Virus
23. Vesicular Stomatitis Virus

RELATED DOCUMENTS:
OSEH GUIDE – SELECT AGENTS
OSEH GUIDE – PATRIOT ACT

If you have a general question or comment about the department, or are unsure who in OSEH to contact, click here and your question will be directed appropriately.